D-0765-2021 Class II Terminated
FDA drug recall D-0765-2021 was initiated by Custopharm, Inc. on July 30, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. The recall status is terminated (terminated August 8, 2022). Affected quantity: 19,384 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 1, 2021
- Initiation Date
- July 30, 2021
- Termination Date
- August 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,384 vials
Product Description
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Reason for Recall
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot# 31327913C, Exp. Date 10/2022